Mobilization of Stem Cells With AMD3100 (Plerixafor) and G-CSF in Non-Hodgkin's Lymphoma and Multiple Myeloma Patients
Study Details
Study Description
Brief Summary
This study evaluates the safety and efficacy of plerixafor given in addition to granulocyte-colony stimulating factor (G-CSF) for collection of peripheral blood stem cells (PBSCs) for autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM). Efficacy outcomes include evaluation of fold increase in circulating CD34+ cells from just before the first plerixafor injection to 10-11 hours post plerixafor (just before apheresis) and assessment of successful polymorphonuclear leukocyte (PMN) engraftment after transplantation. Data from this protocol will assist in the determination of the dosing schedule for future studies.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Participants with NHL and MM who have undergone prior cyto-reductive chemotherapy, are to be autologously transplanted, and meet the inclusion/exclusion criteria are eligible to enter the study. The only change to the standard of care is the addition of plerixafor to a granulocyte colony-stimulating factor (G-CSF) mobilization regimen on the day prior to apheresis. Participants will undergo mobilization with G-CSF (10 mcg/kg each day) and will receive plerixafor (240 mcg/kg) in the evening prior to apheresis. Participants will undergo apheresis for up to 5 consecutive days in order to collect the target number of CD34+ stem cells (≥ 510^6 CD34+ cells/kg for either single or tandem transplant). After apheresis, all participants will be treated with high-dose chemotherapy in preparation for transplantation. Participants will be transplanted with cells obtained from the G-CSF and plerixafor mobilization regimen. The increase in CD34+ cells in the peripheral blood from the time of the plerixafor dose to just prior to apheresis and the number of CD34+ cells in the apheresis product will be measured. The number of apheresis sessions required to obtain ≥ 510^6 CD34+ cells will also be measured. Success of the transplantation(s) will be evaluated by the time to engraftment of polymorphonuclear leukocytes (PMN) and platelets (PLT). Participants will be followed for durability of their transplant for 12 months following transplantation.
This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Non-Hodgkin's Lymphoma (NHL) Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. |
Drug: G-CSF Plus Plerixafor
Participants underwent mobilization with G-CSF 10 µg/kg/day for 4 days, administered by subcutaneous injection (SC) injection each morning. On the evening of Day 4, participants received a dose of plerixafor 240 µg/kg, administered by SC injection. On Day 5, participants returned to the clinic and received a morning dose of G-CSF 10 µg/kg and underwent apheresis approximately 10 to 11 hours after the dose of plerixafor (within 60 minutes after administration of G-CSF). Participants continued to receive an evening dose of plerixafor followed the next day by a morning dose of G-CSF and apheresis for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Other Names:
|
| Experimental: Multiple Myeloma (MM) Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. |
Drug: G-CSF Plus Plerixafor
Participants underwent mobilization with G-CSF 10 µg/kg/day for 4 days, administered by subcutaneous injection (SC) injection each morning. On the evening of Day 4, participants received a dose of plerixafor 240 µg/kg, administered by SC injection. On Day 5, participants returned to the clinic and received a morning dose of G-CSF 10 µg/kg and underwent apheresis approximately 10 to 11 hours after the dose of plerixafor (within 60 minutes after administration of G-CSF). Participants continued to receive an evening dose of plerixafor followed the next day by a morning dose of G-CSF and apheresis for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) [Day 1 to approximately Day 38 (before start of chemotherapy)]
Number of participants with treatment emergent adverse events (TEAEs) collected from Day 1 (start of G-CSF mobilization) to the day before starting chemotherapy (approximately day 38). AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe) and relatedness to study treatment (5 point scale from 'not related' to 'definitely related').
Secondary Outcome Measures
- Number of Participants Achieving a Two-Fold (Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL Following the First Dose of Plerixafor [Days 4-5 (first dose of plerixafor to apheresis)]
The number of participants mobilized with G-CSF + plerixafor injection who have a ≥ 2-fold increase in CD34+ cells. Fold increase was expressed as a ratio. Fold increase = (pre-apheresis PB CD34+ cells/µL) / (pre-plerixafor dosing PB CD34+ cells/µL)
- Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant [2 months]
Participants were monitored for polymorphonuclear leukocyte (PMN) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.
Other Outcome Measures
- Median Cumulative Number of CD34+ Cells Collected During Apheresis [Days 5-8]
Median cumulative total number of CD34+ cells collected during apheresis.
- Number of Transplants in Which Participants Achieved Platelet (PLT) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant [2 months]
Participants were monitored for platelet (PLT) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.
- Number of Participants With Durable Engraftment 12 Months After Transplantation [Approximately 13 months (12 months post-transplant )]
The number of participants maintaining a durable graft 12 months after autologous transplantation. A durable graft is defined as the maintenance of normal blood counts.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosis of non-Hodgkin's lymphoma (NHL) or multiple myoloma (MM) eligible for autologous transplantation
-
No more than 3 prior regimens of chemotherapy
-
More than 4 weeks since last cycle of chemotherapy. Patient recovered from all acute toxic effects of prior chemotherapy.
-
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
-
White blood cell (WBC) count >3.0*10^9/L
-
Absolute polymorphonuclear cells (PMN) count >1.5*10^9/L
-
Platelet (PLT) count >100*10^9/L
-
Serum creatinine <=2.2 mg/dL
-
Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT) and total bilirubin <2 x upper limit of normal (ULN)
-
Left ventricle ejection fraction >45% by normal echocardiogram or multiple-gated acquisition (MUGA) scan
-
Forced expiratory volume of the lung in the first second (FEV1) >60% of predicted or diffusing capacity of the lung for carbon monoxide (DLCO) >45% of predicted
-
Negative for human immunodeficiency virus (HIV) type 1
-
Women of child bearing potential agreed to use an approved form of contraception.
Exclusion Criteria:
-
Patients who have failed previous collections
-
Brain metastases or carcinomatous meningitis
-
History of ventricular arrhythmias
-
A co-morbid condition which, in the view of the investigator, renders the patient at high risk for treatment complications
-
A residual acute medical condition resulting from prior chemotherapy
-
Acute infection
-
Fever (temp >38°C/100.4°F)
-
Patients whose actual body weight exceeds 175% of their ideal body weight
-
Patients who previously received experimental therapy within 4 weeks of enrolling in this study or who are currently enrolled in another experimental study during the mobilization period
-
Positive pregnancy test in female patients
-
Lactating females
-
Patients of child-bearing potential unwilling to implement adequate birth control.
-
Patients who have deterioration of their clinical status or laboratory parameters between the time of enrolment and transplant (such that they no longer meet entry criteria) may be removed from study at the discretion of the treating physician, principal investigator, or sponsor.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | |
| 2 | UCLA School of Medicine | Loa Angeles | California | United States | |
| 3 | Loyola University Medical Center | Maywood | Illinois | United States | |
| 4 | University of Iowa | Iowa City | Iowa | United States | |
| 5 | University of Minnesota | Minneapolis | Minnesota | United States | |
| 6 | Mayo Clinic | Rochester | Minnesota | United States | |
| 7 | Roswell Park Cancer Institute | Buffalo | New York | United States | |
| 8 | Thomas Jefferson University | Philadelphia | Pennsylvania | United States |
Sponsors and Collaborators
- Genzyme, a Sanofi Company
- AnorMED
Investigators
- Study Director: Medical Monitor, Genzyme, a Sanofi Company
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AMD3100-2105
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Non-Hodgkin's Lymphoma (NHL) | Multiple Myeloma (MM) |
|---|---|---|
| Arm/Group Description | Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. | Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. |
| Period Title: Overall Study | ||
| STARTED | 23 | 26 |
| COMPLETED | 21 | 24 |
| NOT COMPLETED | 2 | 2 |
Baseline Characteristics
| Arm/Group Title | Non-Hodgkin's Lymphoma (NHL) | Multiple Myeloma (MM) | Total |
|---|---|---|---|
| Arm/Group Description | Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. | Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. | Total of all reporting groups |
| Overall Participants | 23 | 26 | 49 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
56.5
(8.7)
|
57.6
(8.1)
|
57.1
(8.3)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
9
39.1%
|
10
38.5%
|
19
38.8%
|
| Male |
14
60.9%
|
16
61.5%
|
30
61.2%
|
| Race/Ethnicity, Customized (participants) [Number] | |||
| Caucasian |
23
100%
|
23
88.5%
|
46
93.9%
|
| African-American |
0
0%
|
1
3.8%
|
1
2%
|
| Hispanic/Latino |
0
0%
|
1
3.8%
|
1
2%
|
| Other |
0
0%
|
1
3.8%
|
1
2%
|
Outcome Measures
| Title | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) |
|---|---|
| Description | Number of participants with treatment emergent adverse events (TEAEs) collected from Day 1 (start of G-CSF mobilization) to the day before starting chemotherapy (approximately day 38). AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe) and relatedness to study treatment (5 point scale from 'not related' to 'definitely related'). |
| Time Frame | Day 1 to approximately Day 38 (before start of chemotherapy) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population - all participants who received at least 1 dose of plerixafor. |
| Arm/Group Title | Non-Hodgkin's Lymphoma (NHL) | Multiple Myeloma (MM) | All Participants |
|---|---|---|---|
| Arm/Group Description | Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. | Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. | |
| Measure Participants | 23 | 26 | 49 |
| Participants reporting ≥ 1 Adverse Event |
23
100%
|
26
100%
|
49
100%
|
| AE Severity (Mild) |
8
34.8%
|
9
34.6%
|
17
34.7%
|
| AE Severity (Moderate) |
5
21.7%
|
2
7.7%
|
7
14.3%
|
| AE Severity (Severe) |
10
43.5%
|
15
57.7%
|
25
51%
|
| AE Relationship to Drug (Not Related) |
0
0%
|
4
15.4%
|
4
8.2%
|
| AE Relationship to Drug (Probably Not Related) |
1
4.3%
|
4
15.4%
|
5
10.2%
|
| AE Relationship to Drug (Possibly Related) |
12
52.2%
|
5
19.2%
|
17
34.7%
|
| AE Relationship to Drug (Probably Related) |
8
34.8%
|
11
42.3%
|
19
38.8%
|
| AE Relationship to Drug (Definitely Related) |
2
8.7%
|
2
7.7%
|
4
8.2%
|
| Title | Number of Participants Achieving a Two-Fold (Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL Following the First Dose of Plerixafor |
|---|---|
| Description | The number of participants mobilized with G-CSF + plerixafor injection who have a ≥ 2-fold increase in CD34+ cells. Fold increase was expressed as a ratio. Fold increase = (pre-apheresis PB CD34+ cells/µL) / (pre-plerixafor dosing PB CD34+ cells/µL) |
| Time Frame | Days 4-5 (first dose of plerixafor to apheresis) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The intent-to-treat population (defined as participants who received at least 1 dose of plerixafor). |
| Arm/Group Title | Non-Hodgkin's Lymphoma (NHL) | Multiple Myeloma (MM) | All Participants |
|---|---|---|---|
| Arm/Group Description | Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. | Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. | |
| Measure Participants | 23 | 26 | 49 |
| ≥ 2-fold Increase |
20
87%
|
17
65.4%
|
37
75.5%
|
| < 2-fold Increase |
3
13%
|
9
34.6%
|
12
24.5%
|
| Title | Median Cumulative Number of CD34+ Cells Collected During Apheresis |
|---|---|
| Description | Median cumulative total number of CD34+ cells collected during apheresis. |
| Time Frame | Days 5-8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received at least one dose of plerixafor |
| Arm/Group Title | Non-Hodgkin's Lymphoma (NHL) | Multiple Myeloma (MM) | All Participants |
|---|---|---|---|
| Arm/Group Description | Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. | Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. | |
| Measure Participants | 23 | 26 | 49 |
| Median (Full Range) [CD34+ cells (*10^6 / kg)] |
5.2
|
11.1
|
5.9
|
| Title | Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant |
|---|---|
| Description | Participants were monitored for polymorphonuclear leukocyte (PMN) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment. |
| Time Frame | 2 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received a transplant. Two participants in the MM group received a second transplant. |
| Arm/Group Title | Non-Hodgkin's Lymphoma (NHL) | Multiple Myeloma (MM) | All Participants |
|---|---|---|---|
| Arm/Group Description | Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. | Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. | |
| Measure Participants | 22 | 25 | 47 |
| Measure transplants | 22 | 27 | 49 |
| ≤ Day 12 |
19
|
20
|
39
|
| Day 13 to Day 21 |
3
|
7
|
10
|
| ≥ Day 22 |
0
|
0
|
0
|
| Title | Number of Transplants in Which Participants Achieved Platelet (PLT) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant |
|---|---|
| Description | Participants were monitored for platelet (PLT) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment. |
| Time Frame | 2 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| A total of 47 participants were transplanted. Two participants in the MM group received a second transplant using cells collected on study. One participant in the MM group did not have PLT engraftment information recorded, however did report a durable graft at month 12 post transplant. |
| Arm/Group Title | Non-Hodgkin's Lymphoma (NHL) | Multiple Myeloma (MM) | All Participants |
|---|---|---|---|
| Arm/Group Description | Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. | Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. | |
| Measure Participants | 22 | 24 | 46 |
| Measure transplants | 22 | 26 | 48 |
| ≤ Day 12 |
7
|
7
|
14
|
| Day 13 to Day 21 |
10
|
18
|
28
|
| ≥ Day 22 |
5
|
1
|
6
|
| Title | Number of Participants With Durable Engraftment 12 Months After Transplantation |
|---|---|
| Description | The number of participants maintaining a durable graft 12 months after autologous transplantation. A durable graft is defined as the maintenance of normal blood counts. |
| Time Frame | Approximately 13 months (12 months post-transplant ) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received plerixafor, underwent transplantation, and were evaluable 12 months post transplant. The one participant who did not have a durable graft at 12 months had received chemotherapy for relapse approximately 9 months after transplantation. |
| Arm/Group Title | Non-Hodgkin's Lymphoma (NHL) | Multiple Myeloma (MM) | All Participants |
|---|---|---|---|
| Arm/Group Description | Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. | Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. | |
| Measure Participants | 21 | 23 | 44 |
| Number [participants] |
21
91.3%
|
22
84.6%
|
43
87.8%
|
Adverse Events
| Time Frame | First day of G-CSF administration to the day prior to chemotherapy/ablative treatment in preparation of first transplant. This period includes the G-CSF, plerixafor treatment and rest period. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes events, regardless of reported relationship to study treatment or grade. | |||
| Arm/Group Title | Non-Hodgkin's Lymphoma (NHL) | Multiple Myeloma (MM) | ||
| Arm/Group Description | Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. | Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. | ||
All Cause Mortality |
||||
| Non-Hodgkin's Lymphoma (NHL) | Multiple Myeloma (MM) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Non-Hodgkin's Lymphoma (NHL) | Multiple Myeloma (MM) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/23 (0%) | 1/26 (3.8%) | ||
| General disorders | ||||
| Heparin-induced thrombocytopenia | 0/23 (0%) | 1/26 (3.8%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Non-Hodgkin's Lymphoma (NHL) | Multiple Myeloma (MM) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 23/23 (100%) | 26/26 (100%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 4/23 (17.4%) | 5/26 (19.2%) | ||
| Lymphopenia | 3/23 (13%) | 5/26 (19.2%) | ||
| Thrombocytopenia | 5/23 (21.7%) | 3/26 (11.5%) | ||
| Cardiac disorders | ||||
| Palpitations | 0/23 (0%) | 1/26 (3.8%) | ||
| Eye disorders | ||||
| Ocular hyperaemia | 1/23 (4.3%) | 0/26 (0%) | ||
| Gastrointestinal disorders | ||||
| Abdominal discomfort | 1/23 (4.3%) | 0/26 (0%) | ||
| Abdominal distension | 0/23 (0%) | 2/26 (7.7%) | ||
| Abdominal pain | 4/23 (17.4%) | 0/26 (0%) | ||
| Constipation | 1/23 (4.3%) | 1/26 (3.8%) | ||
| Diarrhoea | 13/23 (56.5%) | 10/26 (38.5%) | ||
| Dyspepsia | 2/23 (8.7%) | 1/26 (3.8%) | ||
| Flatulence | 3/23 (13%) | 1/26 (3.8%) | ||
| Gingival bleeding | 1/23 (4.3%) | 0/26 (0%) | ||
| Hyperchlorhydria | 0/23 (0%) | 1/26 (3.8%) | ||
| Nausea | 9/23 (39.1%) | 8/26 (30.8%) | ||
| Oral pain | 1/23 (4.3%) | 0/26 (0%) | ||
| Paraesthesia oral | 0/23 (0%) | 3/26 (11.5%) | ||
| Salivary hypersecretion | 1/23 (4.3%) | 0/26 (0%) | ||
| Stomach discomfort | 1/23 (4.3%) | 0/26 (0%) | ||
| Vomiting | 1/23 (4.3%) | 1/26 (3.8%) | ||
| General disorders | ||||
| Asthenia | 1/23 (4.3%) | 0/26 (0%) | ||
| Catheter related complication | 1/23 (4.3%) | 1/26 (3.8%) | ||
| Catheter site discharge | 0/23 (0%) | 1/26 (3.8%) | ||
| Catheter site erythema | 1/23 (4.3%) | 0/26 (0%) | ||
| Catheter site haemorrhage | 2/23 (8.7%) | 1/26 (3.8%) | ||
| Catheter site pain | 2/23 (8.7%) | 0/26 (0%) | ||
| Catheter site pruritus | 0/23 (0%) | 1/26 (3.8%) | ||
| Catheter site related reaction | 0/23 (0%) | 2/26 (7.7%) | ||
| Catheter thrombosis | 1/23 (4.3%) | 0/26 (0%) | ||
| Chest discomfort | 1/23 (4.3%) | 1/26 (3.8%) | ||
| Chest pain | 0/23 (0%) | 2/26 (7.7%) | ||
| Chills | 0/23 (0%) | 2/26 (7.7%) | ||
| Fatigue | 7/23 (30.4%) | 4/26 (15.4%) | ||
| Feeling cold | 0/23 (0%) | 1/26 (3.8%) | ||
| Hunger | 2/23 (8.7%) | 0/26 (0%) | ||
| Injection site erythema | 6/23 (26.1%) | 3/26 (11.5%) | ||
| Injection site haemorrhage | 2/23 (8.7%) | 0/26 (0%) | ||
| Injection site irritation | 0/23 (0%) | 1/26 (3.8%) | ||
| Injection site pruritus | 0/23 (0%) | 1/26 (3.8%) | ||
| Injection site swelling | 1/23 (4.3%) | 0/26 (0%) | ||
| Irritability | 1/23 (4.3%) | 0/26 (0%) | ||
| Oedema | 1/23 (4.3%) | 1/26 (3.8%) | ||
| Oedema peripheral | 0/23 (0%) | 1/26 (3.8%) | ||
| Pain | 2/23 (8.7%) | 2/26 (7.7%) | ||
| Pyrexia | 3/23 (13%) | 1/26 (3.8%) | ||
| Secretion discharge | 1/23 (4.3%) | 0/26 (0%) | ||
| Infections and infestations | ||||
| Catheter related infection | 0/23 (0%) | 1/26 (3.8%) | ||
| Oral candidiasis | 0/23 (0%) | 1/26 (3.8%) | ||
| Tooth abscess | 0/23 (0%) | 1/26 (3.8%) | ||
| Upper respiratory tract infection | 1/23 (4.3%) | 0/26 (0%) | ||
| Urinary tract infection | 0/23 (0%) | 1/26 (3.8%) | ||
| Injury, poisoning and procedural complications | ||||
| Blood stem cell harvest failure | 1/23 (4.3%) | 0/26 (0%) | ||
| Neck injury | 1/23 (4.3%) | 0/26 (0%) | ||
| Post procedural discomfort | 1/23 (4.3%) | 0/26 (0%) | ||
| Investigations | ||||
| Alanine aminotransferase increased | 1/23 (4.3%) | 1/26 (3.8%) | ||
| Aspartate aminotransferase increased | 1/23 (4.3%) | 1/26 (3.8%) | ||
| Bacteria stool identified | 0/23 (0%) | 1/26 (3.8%) | ||
| Blood alkaline phosphatase decreased | 0/23 (0%) | 3/26 (11.5%) | ||
| Blood alkaline phosphatase increased | 3/23 (13%) | 6/26 (23.1%) | ||
| Blood lactate dehydrogenase increased | 0/23 (0%) | 1/26 (3.8%) | ||
| Blood magnesium decreased | 1/23 (4.3%) | 0/26 (0%) | ||
| Haemoglobin decreased | 2/23 (8.7%) | 0/26 (0%) | ||
| Heart rate irregular | 1/23 (4.3%) | 0/26 (0%) | ||
| Lymphocyte count abnormal | 1/23 (4.3%) | 0/26 (0%) | ||
| White blood cell count increased | 1/23 (4.3%) | 0/26 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Anorexia | 2/23 (8.7%) | 1/26 (3.8%) | ||
| Hypokalaemia | 5/23 (21.7%) | 2/26 (7.7%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 1/23 (4.3%) | 1/26 (3.8%) | ||
| Back pain | 4/23 (17.4%) | 1/26 (3.8%) | ||
| Bone pain | 7/23 (30.4%) | 6/26 (23.1%) | ||
| Joint stiffness | 0/23 (0%) | 1/26 (3.8%) | ||
| Muscle spasms | 3/23 (13%) | 3/26 (11.5%) | ||
| Muscle twitching | 1/23 (4.3%) | 0/26 (0%) | ||
| Muscular weakness | 1/23 (4.3%) | 0/26 (0%) | ||
| Musculoskeletal discomfort | 1/23 (4.3%) | 1/26 (3.8%) | ||
| Musculoskeletal pain | 2/23 (8.7%) | 2/26 (7.7%) | ||
| Myalgia | 1/23 (4.3%) | 1/26 (3.8%) | ||
| Pain in extremity | 1/23 (4.3%) | 0/26 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Lymphoma | 1/23 (4.3%) | 0/26 (0%) | ||
| Nervous system disorders | ||||
| Dizziness | 0/23 (0%) | 2/26 (7.7%) | ||
| Headache | 9/23 (39.1%) | 4/26 (15.4%) | ||
| Hypoaesthesia | 2/23 (8.7%) | 1/26 (3.8%) | ||
| Migraine | 0/23 (0%) | 1/26 (3.8%) | ||
| Paraesthesia | 4/23 (17.4%) | 11/26 (42.3%) | ||
| Peripheral sensory neuropathy | 2/23 (8.7%) | 1/26 (3.8%) | ||
| Sinus headache | 1/23 (4.3%) | 0/26 (0%) | ||
| Tremor | 1/23 (4.3%) | 1/26 (3.8%) | ||
| Psychiatric disorders | ||||
| Abnormal dreams | 0/23 (0%) | 1/26 (3.8%) | ||
| Anxiety | 3/23 (13%) | 2/26 (7.7%) | ||
| Depression | 0/23 (0%) | 1/26 (3.8%) | ||
| Insomnia | 5/23 (21.7%) | 6/26 (23.1%) | ||
| Nervousness | 1/23 (4.3%) | 1/26 (3.8%) | ||
| Renal and urinary disorders | ||||
| Haematuria | 0/23 (0%) | 2/26 (7.7%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 3/23 (13%) | 2/26 (7.7%) | ||
| Dyspnoea | 0/23 (0%) | 3/26 (11.5%) | ||
| Dyspnoea exertional | 1/23 (4.3%) | 0/26 (0%) | ||
| Nasal congestion | 1/23 (4.3%) | 0/26 (0%) | ||
| Pharyngolaryngeal pain | 1/23 (4.3%) | 1/26 (3.8%) | ||
| Productive cough | 0/23 (0%) | 1/26 (3.8%) | ||
| Rhinorrhoea | 0/23 (0%) | 1/26 (3.8%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Ecchymosis | 1/23 (4.3%) | 2/26 (7.7%) | ||
| Erythema | 1/23 (4.3%) | 0/26 (0%) | ||
| Hyperhidrosis | 1/23 (4.3%) | 1/26 (3.8%) | ||
| Hypoaesthesia facial | 0/23 (0%) | 2/26 (7.7%) | ||
| Night sweats | 3/23 (13%) | 1/26 (3.8%) | ||
| Rash | 0/23 (0%) | 1/26 (3.8%) | ||
| Vascular disorders | ||||
| Haemorrhage | 1/23 (4.3%) | 0/26 (0%) | ||
| Hot flush | 1/23 (4.3%) | 0/26 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
In multi-site studies, PI can publish after Genzyme publishes or 18 months after study completion. PI gives Genzyme a draft 60 days before publication. Genzyme can ask that confidential information be removed, and can defer publication another 60 days upon notifying PI that it will file a patent application on inventions contained in the draft.
Results Point of Contact
| Name/Title | Genzyme Medical Information |
|---|---|
| Organization | Genzyme Corporation |
| Phone | |
| medinfo@genzyme.com |
- AMD3100-2105